New Warning Labels for Non-Steroidal Anti-Inflammatory Drugs (NSAIDS)

In the wake of new research indicating increased risks of heart attacks and strokes, the FDA is requiring new warning labels for nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, which for years have been viewed largely as reliable, over-the-counter solutions to a myriad of common health problems.

On July 9th, 2015, the Food and Drug Administration (FDA) announced that they will create new boxed warnings to alert consumers of the severe health risks that may accompany taking products containing NSAIDs.

NSAIDs are found in many common, over-the-counter drugs that could be in your home’s medicine cabinet or first-aid kit right now. Common NSAIDs such as ibuprofen and naproxen can be found in pain medications such as:

  • Motrin
  • Advil
  • Aleve

These types of anti-inflammatory and pain relieving drugs have a wide range of uses, and are used to treat conditions such as:

  • Osteoarthritis
  • Rheumatoid arthritis
  • Gout
  • Fever
  • Muscle aches
  • Tendonitis
  • Common athletic injuries such as strains and sprains
  • Menstrual cramps
  • And more

Research shows, however, that NSAIDs are not nearly as safe as was previously believed. The new warnings indicate that, even within the first few weeks of using a new NSAID medication, patients can experience an increased risk of suffering a serious heart attack or stroke. It is now also believed that this risk may continue to increase the longer a patient remains on an NSAID medication. The FDA recommends that consumers keep the following facts in mind before taking an NSAID:

  • Never take more than one type of NSAID at a time and do not mix medications.
  • Carefully read and understand the warning labels on all medication before beginning treatment.
  • If you have high blood pressure, have previously suffered a heart attack, stroke, or suffer from cardiovascular disease, be especially careful when taking NSAIDs and consult your doctor before taking these drugs.

The warnings also advise patients to stop taking NSAIDs and seek immediate medical attention if they experience any of the following symptoms, as they may be an indication of heart attack or stroke:

  • Chest pain
  • Trouble breathing or shortness of breath
  • Slurred speech
  • Shooting pain or weakness in one part or side of the body

Heart attack and stroke are a leading cause of death and disability in the United States. The Center for Disease Control estimates that approximately 735,000 Americans experience a heart attack every year, and another 795,000 people suffer a stroke. When prescription or over-the-counter medications are found to increase the average American’s likelihood of suffering one of these debilitating medical emergencies, it is vitally important that everyone is aware of the risks.

Heart attacks and strokes are life-threatening experiences and may result in permanent injury, loss of physical or mental capabilities, and a lifetime of care and treatment.

If you or a loved one has suffered from a heart attack or stroke that you believe was brought on by a defective, dangerous drug, call The Yost Legal Group right away.

Our experienced Baltimore Defective Drug and Personal Injury lawyers have years of experience. We represent people who have been injured after taking a medication that caused a serious adverse reaction.

Call 1-800-YOST-LAW (967-8529) today to speak with one of our experienced, compassionate Baltimore Defective Drug lawyers. We will provide a FREE, confidential and no-obligation consultation and will help you understand the details of your case.

At The Yost Legal Group, our attorneys have both the medical and legal knowledge necessary to provide the answers you seek.

The Yost Legal Group – Experienced Lawyers Dedicated to Protecting Your Rights

Popular Morning Sickness Drug Zofran Linked to Serious Birth Injuries

Nausea and vomiting are common in early pregnancy and may actually serve to protect the developing fetus. Most symptoms of so-called “morning sickness” can be managed conservatively without resorting to medication. This is important because between the years of 1980 and 2014, there were no morning sickness drugs on the market that had passed the Food and Drug Administration’s (FDA) approval process. This approval process is where drug companies must show testing that establishes both the safety and efficacy of their medication. Several previous anti-nausea drugs given to pregnant women caused severe birth defects and were taken off the market as a result.

However, when a drug is approved by the FDA for one use, doctors are free to prescribe it “off-label” for other medical conditions. GlaxoSmithKline (“GSK”) took its popular cancer drug Zofran and marketed it “off-label” for use in pregnant women to help alleviate morning sickness. In spite of the fact that drug companies are prohibited from promoting sales of their drugs for uses which were not safety tested and FDA approved, GSK marketed Zofran “off-label” to obstetricians who often prescribed it to pregnant women. Over 110,000 Zofran prescriptions are estimated to have been written to expecting mothers in 2013 alone. Doctors were not told by the drug company about the risks associated with Zofran.

It is clear that GSK put sales ahead of the safety of their customers.

Studies show that using Zofran during the first 10 weeks of pregnancy doubles a woman’s risk for having a baby with a cleft palate or heart defects. Further research on the potential harm Zofran caused to unborn children is ongoing, but both the FDA and the American College of Obstetricians and Gynecologists have cautioned against the use of Zofran during pregnancy.

The United States brought suit against GSK related to its “off-label” promotion, including the off-label promotion of Zofran for use in treating morning sickness. In 2012, GSK agreed to pay more than a billion dollars to settle the government’s claims.  Now, women across the country are bringing suit against GSK on behalf of their babies who were born with cleft palates, limb deformities, and heart defects.

We at the Yost Legal Group are experienced pharmaceutical and birth injury attorneys.  If you or a loved one has been seriously injured as a result of using Zofran during pregnancy, you may be entitled to compensation.  Call 1-800-YOST-LAW (967-8529) for help.

There is no attorney’s fee or expense unless you recover.

The Yost Legal Group – Experienced Attorneys Dedicated to Protecting Your Rights